The FDA's Deadly Censorship Of Lifesaving E-Cigarette Information

Jacob Sullum
, ContributorI cover the war on drugs from a conscientious objector's perspective.Opinions expressed by Forbes Contributors are their own.

The e-cigarette regulations that the Food and Drug Administration (FDA) unveiled last week pose a grave threat to products that have the potential to dramatically reduce smoking-related disease and death. The most obvious problem for the e-cigarette industry is that manufacturers of vaping equipment and e-liquids must persuade the FDA that allowing their products to remain on the market is “appropriate for the protection of public health”—a challenge that will be prohibitively expensive for all but the biggest companies and may prove impossible even for them. A lawsuit filed this week by Nicopure Labs, which sells e-liquids and vaping hardware, highlights another troubling aspect of the FDA’s regulations: censorship of potentially lifesaving information about e-cigarettes.

(Image: Vaping360)

Even if a few companies survive the shakeout caused by the FDA’s onerous regulations, they will not be allowed to tell consumers the truth about their products. According to the FDA, any intimation that noncombustible, tobacco-free e-cigarettes are safer than the conventional, tobacco-burning kind—which they indisputably are—transforms them into “modified risk tobacco products,” which can be marketed only with prior approval. To get the FDA’s permission, an applicant must demonstrate that its product will not only “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users” but also “benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.”

The upshot is that any e-cigarette company selling its products as a less hazardous alternative to the real thing would render them “adulterated,” inviting FDA seizure. That could happen even if a company truthfully described its product as “smokeless” or “smoke-free.” The FDA says it will “evaluate an [e-cigarette] manufacturer’s use of ‘smokeless’ or ‘smoke-free’ (and similar descriptive terms) on a case-by-case basis.” The FDA also looks askance at e-cigarette manufacturers who “advertise that [their products] do not contain tobacco”—a perfectly accurate statement, albeit a potentially confusing one in light of the agency’s arbitrary decision to treat e-cigarettes as “tobacco products.” The agency’s rationale for applying that label to products that contain no tobacco is that the nicotine in e-cigarettes is derived from tobacco, an argument that also turns nicotine gum, patches, lozenges, sprays, and inhalers into tobacco products.

If e-cigarette companies are asking for trouble merely by accurately describing their products, it should go without saying that they are not allowed to talk about the main advantage of vaping: It is something like 95% less hazardous than smoking because it exposes consumers to far fewer toxins and carcinogens in far lower doses. Even a straightforward chemical comparison of the aerosol produced by an e-cigarette and the smoke produced by a tobacco cigarette is forbidden, lest it lead consumers to the accurate conclusion that they can dramatically reduce the health risks they face by vaping instead of smoking. In other words, the FDA is actively suppressing truthful information that would encourage people to make healthier choices.

Nicopure’s lawsuit argues that the FDA’s censorship “violates the First Amendment by prohibiting manufacturers, including Nicopure, from making truthful and nonmisleading statements regarding vaping devices, e-liquids, and related products.” Although the FDA dismisses First Amendment concerns about its regulations, it seems to me that Nicopure has a strong case. The Supreme Court has arbitrarily declared that “commercial speech” receives less First Amendment protection than other kinds of expression. But restrictions on what businesses say while trying to sell people stuff still must meet a pretty strict test: As long as the speech is not misleading and concerns legal activity, regulations must be narrowly tailored to directly advance a substantial government interest.

One is hard pressed to identify any legitimate interest that the FDA advances by preventing an e-cigarette company from saying its product does not contain tobacco, does not produce smoke, and generates fewer toxins at lower levels than conventional cigarettes do. When the FDA announced its regulations, it claimed “FDA is taking this action to reduce the death and disease from tobacco products.” Its speech restrictions undermine that goal, impeding the success of products that the Royal College of Physicians says have “the potential to prevent almost all the harm from smoking.”